Description of Event or Problem · 1
THE PT HAD METASTATIC CANCER FROM RENAL CELL CARCINOMA INVOLVING THE POSTERIOR MEDIASTINUM, SUPERIOR MEDIASTINUM, RIGHT SUBCLAVIAN REGION, AND RIGHT NECK. THERE WAS OBSTRUCTION OF THE RIGHT SUBCLAVIAN VEIN AND BRACHIOCEPHALIC TRUNK WITH A RESULTING SUPERIOR VENA CAVA SYNDROME. THE PLACEMENT OF A METALLIC WALLSTENT IN THE BRACHIOCEPHALIC TRUNK AND ADJACENT VENA CAVA DIRECTLY ABOVE THE HEART WAS PLANNED. THE STENT WAS INTRODUCED THROUGH A 9 FRENCH VASCULAR SHEATH WHICH HAD BEEN PLACED IN THE BRACHIAL VEIN BY PROVIDING VENOUS ACCESS IN THE ANTECUBITAL AREA OF THE RIGHT ARM. THE STENT CATHETER ASSEMBLY WAS ADVANCED UNDER FLUOROSCOPIC VISUALIZATION INTO THE AREA OF THE BRACHIOCEPHALIC TRUNK MASS. DURING DEPLOYMENT A SLIGHT (5MM OR LESS) SHIFT IN THE INTENDED POSITION OF THE STENT TOWARD THE RIGHT ATRIUM WAS NOTED AS HAVING TAKEN PLACE, RESULTING IN THE END OF THE STENT WHICH WAS NEAREST TO THE HEART BEING PARTIALLY LOCATED BEYOND THE AREA OF STENOSIS AND INTO THE MORE NORMAL DIAMETER LUMEN OF THE NONSTENOTIC PORTION OF THE SUPERIOR VENA CAVA IMMEDIATELY ABOVE THE HEART. ADJUSTMENT IN THE POSITION OF THE STENT WAS NOT POSSIBLE. WITHIN AN HOUR OF STENT PLACEMENT, PT BEGAN TO EXPERIENCE ACUTE SYMPTOMS OF RESPIRATORY DISTRESS AND HYPOTENSION. WITHIN FIFTEEN MINUTES OF THE ONSET OF THESE ACUTE SYMPTOMS THE PT WAS PULSELESS AND WITHOUT SPONTANEOUS RESPIRATIONS. AN AUTOPSY PERFORMED WITHIN SIXTEEN HOURS OF THE TIME OF DEATH REVEALED A METALLIC WALLSTENT DEVICE THAT HAD FLARED OPEN ON THE END CLOSEST TO THE HEART IN THE NONSTENOSED LUMEN OF THE SUPERIOR VENA CAVA.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER, OTHER, UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE, OTHER. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.